NDC 0024-4142

Multaq

Dronedarone

Multaq is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Dronedarone.

• Product ID: 0024-4142_14993a42-d5f1-438a-bb4f-c2de7ef68e83
• NDC: 0024-4142
• Product Type: Human Prescription Drug
• Proprietary Name: Multaq
• Generic Name: Dronedarone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022425
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: DRONEDARONE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0024-4142-06

8 BLISTER PACK in 1 BOX (0024-4142-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0024-4142-60 [00024414260]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-01

NDC 0024-4142-06 [00024414206]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

NDC 0024-4142-50 [00024414250]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

NDC 0024-4142-10 [00024414210]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-01

NDC 0024-4142-18 [00024414218]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-01
• Marketing End Date: 2017-03-21

Drug Details

Active Ingredients

Ingredient	Strength
DRONEDARONE	400 mg/1

OpenFDA Data

• SPL SET ID: 7fa41601-7fb5-4155-8e50-2ae903f0d2d6
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • JQZ1L091Y2
• RxNorm Concept Unique ID - RxCUI:
  • 854856
  • 854859
• PHarm Class EPC:
  • Antiarrhythmic [EPC]
• NUI Code:
  • N0000175426

Pharmacological Class

• Antiarrhythmic [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "Multaq" or generic name "Dronedarone"

NDC	Brand Name	Generic Name
0024-4142	Multaq	Dronedarone
53360-4142	Multaq	dronedarone
55154-8104	Multaq	Dronedarone